Manual Therapy on Balance and Mood States

Young Adult Clinical Trial

— MTBMood  

Official title:

Effect of a Manual Therapy Protocol on Balance and Mood States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444414
• Other study ID #: ID0030
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: January 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study was to compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants. This study will consist of a randomized controlled trial. Participants will be healthy subjects divided into 2 groups, being an experimental group that will receive a manual therapy session and a control group without treatment. It will be evaluated at the start of the study, after treatment and one week later.

Description:

Background

Evidence suggest that the application of manual therapy could be effective in multiple pathologies, but there are few studies which have investigated the effectiveness of manual therapy in to balance and mood states.

Objective To compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants.

Metods

This is a randomized controlled trial which will be carried out with young adults. The sample will be divided into 2 groups: a) experimental group that will receive a manual therapy session; b) a control group without treatment. All subjects signed the informed consent and confidentiality of the data was reserved according to the Helsinki declaration. The treatments were carried out in the laboratories of the University of Valencia and the project was approved by the institution's ethics committee.

The experimental group to receive manual therapy (Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening). The control group will not receive treatment and only evaluations will be performed.

Outcomes

The evaluations will consist of the following variables: Star Excursion Balance Test (SEBT), Unipedal Stance Test (UPST), Patient Global Impression of Change (PGIC) and POMS (Profile Of Mood States). Evaluations will be carried out at three times: at the beginning of the study, after treatment and one week later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 1, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 30 years

• That they can take all the tests from the study evaluations.

Exclusion Criteria:

• Those who are doing some balance training program.

• Individuals who have some deterioration in balance, regardless of whether the cause is the vestibular system, the visual, proprioceptive, any surgery.

• Participants suffering from tingling or numbness.

• Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.

• That the lower limbs or in the lumbosacral region have orthopedic problems or traumatic injuries, they will not be able to participate either, including as such scoliosis, ligament pathologies, osteoarthritis, prostheses.

• Pregnancy.

Related Conditions & MeSH terms

• Young Adult

Intervention

Other:
• Manual therapy
bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.
• Control group
The control group received no treatment, they only attended the evaluations.

Locations

Country	Name	City	State
Spain	Gemma Espí	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22. — View Citation

Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Star Excursion Balance Test (SEBT)	It consists of reaching the lower limb as much as possible, in a standing position, while the other lower limb is kept on a stable support base, at a certain point. The reaches of the leg are evaluated using three determined directions, such as the anterior, the postero-medial and the postero-lateral.	1-week
Secondary	Unipedal Stance Test (UPST)	It consists of a test to measure static balance. Subjects who focus on a fixed point that is marked on the wall and perform the single-legged support. Before lifting the lower limb to be assessed, which will determine the start of the test, the subjects have to cross their arms at chest level, placing their hands on the opposite shoulders. When the subject is ready, close the eyes and raise the lower limb, and the time it is capable of holding is measured with a stopwatch. It is performed later with the other leg	1-week
Secondary	Patient Global Impression of Change (PGIC)	reflects the patient's belief about the effect of the treatment applied. This tool evaluates this perception on a scale that ranges from 1 (the patient is much better) to 7 (the patient is much worse). It also consists of a visual analog scale that classified the improvement from 0 to 10, with the first value being a very good improvement and the second being a significant worsening after treatment.	1-week
Secondary	POMS (Profile Of Mood States)	The POMS is a questionnaire which aims to measure the state of mind. It consists of 58 items, valued using a Likert-type format, with 5 possible response alternatives. From this test, a general index of mood alteration and thirst can be extracted, partially measured: Tension, Depression, Cholera, Vigor, Fatigue and Confusion. Although the POMS has been described as a redundant ladder, it appears to be a multidimensional instrument, with high internal consistency and a relatively stable factor structure.	1-week